Interactions with Industry Office for Interactions with Industry Partners HealthCare Updated October 31 2014 Click PLAY or FORWARD to move through the slides What do I need to know about interactions with industry ID: 361022
Download Presentation The PPT/PDF document "An Introduction to Partners Policies on" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
An Introduction to Partners Policies on
Interactions with Industry
Office for Interactions with IndustryPartners HealthCareUpdated October 31, 2014
Click
PLAY
or FORWARD to move through the slides. Slide2
What do I need to know about interactions with industry?Slide3
Decisions and judgments relating to our charitable activities should be based on the best interests of our patient care, research and educational missions.
External
financial interests create the concern that our decisions may be biased, or be perceived as being biased, by those financial interestsClinical Care – are patients’ interests foremost?Research – is the design, conduct, and reporting of research objective?
Education – is
the audience receiving unbiased information
?Bias can be real, but even the perception of biased decision-making can damage the individual’s and institution’s reputation, erode public trust and undermine Partners hospitals’ charitable activities – and create legal exposures.
Why is COI a concern?Slide4
What do I need to know?
The remainder of this tutorial will tell you about Partners rules and help you to manage your relationships with industry in a positive way. Topics include:
Outside Activities, including giving talks
Gifts
Industry Support of Educational Activities
Research and Personal Financial InterestsThe Office for Interactions with Industry (OII) and your Compliance Officer are here to help you to navigate the relevant Partners policies and procedures
!
Understanding Partners PoliciesSlide5
What is an Outside Activity?
Two Separate Paths can lead to an Outside Activity
Engagement in an activity beyond the scope of what you do at Partners
Activity that requires the expertise you use in your Partners position
Activity that involves a company that does or could do business with Partners, even a non-medical one
OR
OUTSIDEACTIVITY
OUTSIDE
ACTIVITYSlide6
What is an Outside Activity?
If
you have any questions about existing or new Outside Activities, please contact OII
!
Consulting, scientific advisory boards or Board of Director positions for:
Pharmaceutical companies
Medical device companiesFinancial services companies
Any other vendor or likely vendor of
Partners
Giving talks or a training presentation paid for by a commercial company
Online medical evaluations for non-Partners organizations
Expert
witness work
Examples of Outside ActivitiesSlide7
Serving in an executive position of a for-profit company engaged in commercial or research activities of a biomedical nature (for full-time HMS faculty and Institutional Officials only)
Certain types of company-paid speaking engagements (more on this later)
Ghostwriting
Prohibited Activities
What requirements are there around Outside Activities?
Partners
encourages and
supports engaging in outside activities. Most are allowable.
Only
a few are prohibited.Slide8
Compensation
– Payment should not exceed fair market value for time spent
Time – Medical staff who are full-time HMS faculty may spend up to 20% of working time on Outside Activities, not to exceed one day a week, unless limited by your supervisor. Non full-time HMS faculty must check with your supervisor about time permitted on Outside Activities.
Institutional resources
– For your Outside Activities, you
cannot make substantial use of institutional resources (space, materials, staff).Use of name/ Intellectual Property – Company may not use Partners & Partners hospitals’ names or claim Partners IP.General – The activity must be conducted so that the time and creative energy does not, in the supervisor’s judgment, compromise or interfere with individual’s responsibilities at Partners
Outside Activities have limits regarding
Written agreements are required when the outside activity is with an outside entity that is a pharmaceutical, medical device or biotechnology company or a vendor or potential vendor of Partners.
Most agreements require review by OII.,
to ensure compliance with institutional policies
Many arrangements also need supervisor approval
Consult OII’s Consulting & Outside Activities web page for details about when agreements require review and whether supervisor approval is required.
http://pulse.partners.org/OII/ConsultingHome.html
Partners policies require a written agreement for most Outside Activities
What requirements are there around Outside Activities?Slide9
What do I need to know about giving talks?
If talk is part of CME event hosted by ACCME accredited provider (or equivalent)
If presentation is hosted by, and pay is from, a professional society or academic institution
If presentation is hosted or directly paid for by a company, provided that the speaker has
FULL
control of content and the talk is not otherwise prohibited
OK
If talk is hosted or directly paid for by a company, it is not OK if
It is called a “Speakers Bureau”
The company has control over content
The speaker has agreed to be on a company-held list of available speakers
The speaker is engaged in promotional activity for the company
(See g
uidelines for determining whether an activity is promotional on OII’s web site.)
Not OK
Not sure?
Call OII
More than 6 talks or presentations/year/company
is
not allowed without
approval from the Committee on Outside Activities
(
formerly called the Committee on Conflicts of Interest)
.Slide10
What kind of gifts are acceptable?
No gifts may be accepted from vendors or potential vendors. Includes all vendors, not just drug & device companies.
*Are there times when a meal is not a gift? See FAQs, scenarios on OII’s web
page.
Entertainment: tickets, rounds of golf
Trinkets: pens
, mugs, tote bags Conference giveaways
Food/Meals *
NO GiftsSlide11
What do I need to know about Purchasing?Slide12
What do I need to know about Industry Support of Partners Educational Activities?
All
industry support of Partners educational activities must be processed through OII
!
Funding for a specific program must come from more than one company
Conferences must meet the standards of the ACCME or comparable standards, even if not for CME credit
Training programs, including residency and
clinical fellowship programs Educational events, such as Grand Rounds, lectures and conferences Newsletters and websites designed to deliver educational content
Program Requirements
Examples of Partners Educational ActivitiesSlide13
What do I need to know about Research?
Special concerns about conflicts of interest in research
Objectivity of data, conclusions impacted
Misuse of human subjects or patients; injury or worse
Misuse/ exploitation of students, trainees, junior faculty who are involved in research enterprise of conflicted supervising researcherSlide14
What do I need to know about Research?
Many research collaborations with industry are allowed and encouraged.
However, just a few arrangements are
not
okay:
Doing clinical research (regardless of funding source)
on the technology
of a company in which you/your family has financial interests (includes stock, other forms of equity, cash income), except if the only financial interest is cash income that does not exceed $10k/year.
Receiving research support either from a publicly traded company in which you/your family owns equity (stock, stock options, other ownership interests) with value greater than $30,000 or any equity in a privately held company.
Receiving research support from a company, or doing research on a technology of a company for which you serve on the
Board of DirectorsSlide15
The Partners Commission for Interactions with
Industry recommended implementing a policy and process for managing conflicts in clinical care.
In 2013, the Partners Committee on Outside Activities (formerly called the Committee on Conflicts of Interest) established a physician task force to study the issue in-depth. Recommendations from the Task Force are under consideration by Partners Leadership. Stay tuned!
What’s Ahead: Conflicts in Clinical CareSlide16
Where can I learn more?
The Partners Policy for Interactions with Industry is posted at :
http://www.partners.org/About/Ethics/Interactions-With-Industry/Policy.aspx
The key sections of the Policy are:
Section 1: Researchers’ Financial Interests and Outside Activities Related to Research and Financial Conflicts of Interest
Section 2: Clinical Care and Interactions with IndustrySection 3: Industry Support Related to EducationSection 4: Consulting and Other Outside ActivitiesSection 5: Institutional Conflicts of Interest
Partners Policy
Guidelines, FAQs, Resources and Forms related to Consulting Agreements, Industry Support for Educational Activities, Partners Disclosure Forms, Speaking Engagements, NIH Regulations affecting Sponsored Research
OII web siteSlide17
If you have questions, your Compliance Officer is knowledgeable about these issues and can help you work through them.
If you are entering into a new consulting or other outside activity, contact OII or visit OII’s web page.
Where can I get more help?Office for Interactions with Industry
Partners HealthCare
617-643-7752
PHSOII@partners.orgYour Compliance Officer and OII
are here to help!Slide18
To receive HealthStream credit, close this window,
return to instructions window, and click Exit Lesson.
To track CE/CME credit for any HealthStream course, update your information under theMy Profile tab > Manage Discipline and License Information